Using 3D Printing, MakerBot and Feinstein Institute for Medical Research Create Cartilage to Repair Tracheal Damage

Results are showcased at 51st Annual Meeting
of The Society of Thoracic Surgeons

SAN DIEGO--(BUSINESS WIRE)--
Investigators at The Feinstein Institute for Medical Research have made
a medical breakthrough using 3D printing on a MakerBot® Replicator® 2X
Experimental 3D Printer to create cartilage designed for tracheal repair
or replacement. The results were reported today at the 51st
Annual Meeting of The Society of Thoracic Surgeons in San Diego, in a
presentation by Todd Goldstein, an investigator at the Feinstein
Institute, part of the North Shore-LIJ Health System. This is a first
for medical research where regular MakerBot PLA Filament was used to 3D
print a custom tracheal scaffolding, which was combined with living
cells to create a tracheal segment.

Daniel A. Grande, PhD, director of the Orthopedic Research Laboratory at the Feinstein Institute, and Todd Goldstein, an investigator at the Feinstein Institute, part of the North Shore-LIJ Health System, with their MakerBot Replicator Desktop 3D Printer that they used to 3D print cartilage to repair tracheal damage. (Photo: Business Wire)

Mr. Goldstein, a PhD candidate at the Hofstra North Shore-LIJ School of
Medicine, has been working with a team of surgeons at the North
Shore-LIJ Health System for the past year on determining if 3D printing
and tissue engineering could be used for tracheal repair and
replacement. Tracheal damage can be caused by tumor, endotracheal
intubation, blunt trauma, and other injuries. Narrowing and weakness of
the trachea can occur and are often difficult to repair. There have been
two traditional means of reconstructing a damaged trachea, but both
techniques have limitations. Lee Smith, MD, chief of pediatric
otolaryngology at Cohen Children's Medical Center and David Zeltsman,
MD, chief of thoracic surgery at Long Island Jewish Medical Center, both
part of the North Shore-LIJ Health System, came to Mr. Goldstein and
Daniel A. Grande, PhD, director of the Orthopedic Research Laboratory at
the Feinstein Institute, and asked if 3D printing might offer a
solution. Drs. Smith and Zeltsman originally surmised that incorporating
3D printing and tissue engineering to grow new cartilage for airway
construction might be possible in ten to 20 years. Mr. Goldstein and Dr.
Grande did it in a month.

The Feinstein Institute's research combined two emerging fields: 3D
printing and tissue engineering. Tissue engineering is like other kinds
of engineering, except instead of using steel or computer code to make
things, living cells from skin, muscle or cartilage are the raw
material. Researchers at the Feinstein Institute know how to make
cartilage from a mixture of cells called chondrocytes, nutrients to feed
them, and collagen, which holds it all together. Shaping that cartilage
into a nose or a windpipe is another matter. That's where 3D printing
comes in. A 3D printer can construct scaffolding, which can be covered
in a mixture of chondrocytes and collagen, which then grows into
cartilage.

"Making a windpipe or trachea is uncharted territory," noted Mr.
Goldstein. "It has to be rigid enough to withstand coughs, sneezes and
other shifts in pressure, yet flexible enough to allow the neck to move
freely. With 3D printing, we were able to construct 3D-printed
scaffolding that the surgeons could immediately examine and then we
could work together in real time to modify the designs. MakerBot was
extremely helpful and consulted on optimizing our design files so they
would print better and provided advice on how to modify the MakerBot
Replicator 2X Experimental 3D Printer to print with PLA and the
biomaterial. We actually found designs to modify the printer on
MakerBot's Thingiverse website to print PLA with one extruder and the
biomaterial with the other extruder. We 3D printed the needed parts with
our other MakerBot Replicator Desktop 3D Printer, and used them to
modify the MakerBot Replicator 2X Experimental 3D Printer so that we
could better iterate and test our ideas."

"The ability to prototype, examine, touch, feel and then redesign within
minutes, within hours, allows for the creation of this type of
technology," says Dr. Smith. "If we had to send out these designs to a
commercial printer far away and get the designs back several weeks
later, we'd never be where we are today."

The Feinstein Institute had looked previously at other 3D printers that
can extrude living cells, but the options are few and expensive. One
special bio printer cost $180,000, an amount that the Institute would
not allocate. They wanted to test their concept and see if it would be
viable, so they decided to use the more affordable and accessible
MakerBot Replicator 2X Experimental 3D Printer that retails for $2,499
and is a size that fits on a desktop.

Originally, Mr. Goldstein thought that he would need special PLA to
maintain sterility and have the ability to dissolve in the body.
However, in light of time, they decided to try regular MakerBot PLA
Filament. "The advantage of PLA is that it's used in all kinds of
surgical implant devices," says Dr. Smith. Through testing, Mr.
Goldstein found that the heat from the extruder head sterilized the PLA
as it printed, so he was able to use ordinary MakerBot PLA Filament.

The bio-ink, which stays at room temperature, is extruded during the 3D
printing process and fills in gaps in the PLA scaffolding, then cures
into a gel on the heated build plate of the MakerBot Replicator 2X. A
two-inch-long section of windpipe — shaped like a hollowed-out Tootsie
Roll — takes less than two hours to print. Once the bio-ink adheres to
the scaffolding, it goes into a bioreactor, an appliance like a
rotisserie oven that keeps the cells warm and growing evenly. A new
bioreactor costs between $50,000 and $150,000, so Mr. Goldstein
customized an incubator for his needs, making gears and other parts on
their MakerBot Replicator Desktop 3D Printer to produce a brand new
bioreactor.

"The research being done at the Feinstein Institute is exciting and
promising," noted Jenny Lawton, CEO of MakerBot. "We are continually
amazed by what is being created with 3D Printers. To know that a
MakerBot Replicator 3D Printer played a role in a potential medical
breakthrough is inspiring."

The results of the study, as presented by Mr. Goldstein and Dr. Zeltsman
at The Society of Thoracic Surgeons, illustrate how the 3D printed
windpipe or trachea segments held up for four weeks in an incubator.
According to Mr. Goldstein's abstract, "The cells survived the 3D
printing process, were able to continue dividing, and produced the
extracellular matrix expected of tracheal chondrocytes." In other words,
they were growing just like windpipe cartilage.

The Feinstein Institute describes this work as a "proof of concept." The
team still has work to do before establishing a new protocol for
repairing damaged windpipes. Medical research can take years to move
from bench to bedside, as can US Food and Drug Administration (FDA)
approval. However, if there is no approved treatment for an ailment, the
FDA has a compassionate therapy exception that allows the patient to
agree to try an experimental approach.

According to Dr. Smith, at least one patient comes through the North
Shore-LIJ Health System each year who can't be helped by the two
traditional methods, and he expects in the next five years to harvest a
patient's cells, grow them on a scaffolding, and repair a windpipe. This
customized approach may prove to be especially useful for treating
children, says Dr. Smith. "There's really a limitless number of sizes
and permutations you might need to reconstruct an airway in a child."

When speaking about his work with 3D printing and this research, Mr.
Goldstein notes, "It's completely changed the trajectory of my academic
career." Mr. Goldstein originally came to the Feinstein Institute as a
molecular biologist, working with cells, chemicals and drugs. Combining
this knowledge with 3D printing and getting into tissue engineering is
something he didn't expect that at all when he joined the Feinstein
Institute.

Now he is the Feinstein Institute's 3D printing specialist, printing
models of organs for pre-operative planning and tools to improve the
lab. He is the presenting author on a paper being presented to thousands
of surgeons, and applying for major grants to continue his research.
"Knowing that I can make a part that will save someone's child — that's
life-changing," said Mr. Goldstein.

"This project will probably define my scientific career," says Dr.
Smith. "As we produce something that can replace a segment of trachea,
we'll constantly be modifying and optimizing, the correct bio materials,
the correct way to bond the cells to the scaffold. 3D printing and
tissue engineering has the potential to replace lots of different parts
of the human body. The potential for creating replacement parts is
almost limitless."

MakerBot has also supplied the Feinstein Institute with early samples of
its just-announced MakerBot PLA Composite Filaments in Limestone
(calcium carbonate) and Iron, which will be available commercially later
this year, so the Feinstein Institute can start investigating how to
engineer other kinds of tissue, like bone or 3D print custom-made
shields for cancer and radiation treatment.

"Do you remember the Six Million Dollar Man?" asks Dr. Grande. "The
Bionic Man is not the future, it's the present. We have that ability to
do that now. It's really exciting."

About MakerBot

MakerBot, a subsidiary of Stratasys Ltd. (Nasdaq: SSYS), is
leading the Next Industrial Revolution by setting the standards in
reliable and affordable desktop 3D printing. Founded in 2009, MakerBot
has built the largest installed base of desktop 3D printers sold to
innovative and industry-leading customers worldwide, including
engineers, architects, designers, educators and consumers. To learn more
about MakerBot, visit makerbot.com.
To learn more about Thingiverse, visit thingiverse.com.

About the Feinstein Institute for Medical Research

Headquartered in Manhasset, New York, The
Feinstein Institute for Medical Research is home to international
scientific leaders in many areas including Parkinson's disease,
Alzheimer's disease, psychiatric disorders, rheumatoid arthritis, lupus,
sepsis, human genetics, pulmonary hypertension, leukemia,
neuroimmunology, and medicinal chemistry. The Feinstein Institute, part
of the North Shore-LIJ Health System, ranks in the top 6th percentile of
all National Institutes of Health grants awarded to research centers.
For more information, visit FeinsteinInstitute.org.